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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The warning letter posted on Tuesday took issue with the firm’s May response to the 13 inspectional citations outlined in a Form 483, following an inspection conducted by FDA investigators between March and April. Mylan was quick to issue a response to the warning.

“Mylan has proactively discontinued a number of products from the site while also transferring some products to other sites. These actions have led to a temporary disruption in supply of certain Mylan products for customers,” the firm said on Tuesday, adding that the latest warning letter to its Morgantown plant is “the sole outstanding FDA warning letter to Mylan.”

The new enforcement action comes at a time when regulatory authorities across several countries are grappling with a shortage of Mylan’s EpiPen. Pfizer and Mylan also reported earlier this month a labeling defect on EpiPen 0.3 mg and EpiPen Jr 0.15 mg formats could prevent the autoinjectors from administering epinephrine.

FDA also dinged the company’s site for an insufficient cleaning program and a lack of an “adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.” A repeat GMP violation is “the unjustified invalidation of failing test results.”

The agency also found the firm’s response insufficient in that it lacked evidence in support of a validated cleaning program and a comprehensive retrospective evaluation of all investigations for implementation of an appropriate corrective and preventive action (CAPA) plan. The firm’s facility “lack of rigorous oversight of manufacturing changes continues to be a major factor in the unexpected variation observed in your drug products,” according to the agency investigators.

Mylan’s facility had yet to complete several of its commitments regarding initiated CAPAs at the time of its response to the 483, despite set 2017 due dates, as previously reported by Focus.

The warning letter noted FDA cited similar violations across three Mylan facilities and Mylan Laboratories since 2015. “These repeated failures at multiple sites demonstrate that Mylan’s management oversight and control over the manufacture of drugs is inadequate,” FDA said.

A 2017 FDA warning letter to an India-based Mylan facility identified a repeat observation from 2015 regarding unidentified trends in OOS investigations. “We continuously learn from inspections of our facilities by FDA and other authorities as regulatory expectations continue to evolve,” the firm added in its Tuesday response. “In 2018, global health authorities conducted more than 100 regulatory inspections, including 21 FDA inspections, of our nearly 50 other manufacturing facilities around the world without regulatory action or significant observations.”

Ronny Gal, a senior analyst at Bernstein Research, discussed his thoughts on the latest warning letter to Mylan in a new report. He argued it will be challenging for Mylan to lift the letter.

“The saving grace is that there is no immediate impact to near term high value launches,” Gal said. “The biosimilars, Advair, and we believe Restasis do not come from Morgantown.” He also suggested a shutdown of the Morgantown facility based on a “systemic risk for the company,” the unlikelihood that the facility is “currently above marginal profitability” over costs associated with remediation and the US remaining the “higher cost manufacturing site in the global system.”